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A New Era in Cervical Cancer Screening to Improve Women’s Health

In 2014, the U.S. FDA approved the cobas® HPV Test as a first-line primary screening test for cervical cancer. This means that the cobas® HPV Test can now be used to replace the Pap test, if the doctor chooses to do so for primary screening.

In March 2014, a panel of experts advised the FDA that it was as safe and effective using the cobas® HPV Test in place of the Pap test as a first line test to screen for cervical cancer. In April 2014, the FDA made a decision to approve the cobas® HPV Test as a first-line, primary screen in women ages 25-65 years of age. It is the first and only FDA-approved test for first-line primary screening for cervical cancer.

The cobas® HPV Test is a more sensitive than the Pap test to identify women at risk of developing cervical cancer. The cobas® HPV Test was proven safe and effective for cervical cancer screening in a scientific study named ATHENA. This was the largest US study of its kind which included over 47,000 women.

The cobas® HPV Test is the only test approved by the FDA to be used as a first-line primary screening test for cervical cancer in women ages 25-65. This test individually identifies HPV 16 and HPV 18 along with a pooled result for 12 other high-risk HPV types. HPV 16 and HPV 18 are the highest risk types and known to cause about 70% of all cervical cancers.

The sample is collected in exactly the same way as it is for the Pap test. Your healthcare provider will use an instrument, called a speculum, to look into your vagina. Another device is then inserted to collect cell samples from the cervix. The samples are placed in a liquid bottle and sent to a laboratory for the HPV test.

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